Botox® for Migraine

Botox® (botulinum toxin A) was licensed specifically for the treatment of chronic migraine in July 2010 by the Medicines and Healthcare products Regulatory Agency (MHRA). Botox® has not been shown by clinical research to be effective for any other headache type (e.g. episodic migraine, tension-type headache, cluster headache) as yet.


What is Botulinum toxin?

Botulism – paralysis of muscles caused by high doses of botulinum toxin – was first described in 1817. The responsible bacterium, Clostridium botulinum, was not isolated until 1895. Seven different subtypes of botulinum toxin (A-G) are known. A highly dilute preparation of botulinum toxin type A (Botox®) was introduced in clinical practice in the 1970s and 1980s to treat squint and blepharospasm. Since then it has found uses in other areas of medicine including dystonia ,cerebral palsy,  post-stroke spasticity, and hyperhidrosis, among other clinical uses.


Botulinum toxin and headache

In the mid-1990s a number of people reported improvement in headaches in patients receiving botulinum toxin for other reasons. Well-conducted clinical trials of botulinum toxin in various types of headache followed, but the results were disappointing, with no difference over placebo being found in tension-type headache, episodic migraine, and undifferentiated chronic headache. Detailed analysis of the results suggested, however, that there might be a subgroup of patients with chronic migraine who could benefit, and further trials were undertaken.


Botox® in chronic migraine: the PREEMPT trials

Two Phase 3 Research Evaluating Migraine Prophylaxis Therapy (PREEMPT) trials recruited 1384 patients with chronic migraine, and randomised them to treatment with Botox® or placebo. These patients were suffering on average 20 days of headache each month, of which 18 were moderate or severe. Those randomised to Botox® received fixed-site, fixed dose injections every 12 weeks over 56 weeks. These injections covered seven specific areas of the head and neck, with a total dose of between 155-195 units. At six months, after two cycles of treatment, those treated with Botox® had on average eight less days of headache each month. After 12 months, 70% of those treated had ≤50% the number of headaches that they had done originally. Botox® was well-tolerated, the commonest side effects being neck pain (6.7%), muscular weakness (5.5%), and drooping of the eyelid (3.3%). No serious irreversible side effects have ever been reported in trials of Botox® in headache.


How does botulinum toxin work in chronic migraine?

The simple answer is that we don’t know – yet. Unlike many of the other conditions in which it is used, it is not thought to work by relaxing overactive muscles. Botulinum toxin has been shown to reduce pain in a number of disease states, including cervical dystonia, neuropathic pain, lower back pain, spasticity, myofascial pain, and bladder pain. Botulinum toxin is believed to inhibit the release of peripheral nociceptive neurotransmitters, which may then have a knock-on effect on the central pain processing systems that generate migraine headaches.


How long does the procedure take?

At The Head Clinic we like to take 40 mins, 20mins  to take a good history about your migraine pattern to ensure this treatment is the correct course of action for you. If we decide it is and you have read and understood all the information, and had any questions answered we will proceed.

The PREEMPT protocol for injections involves 31-39 very quick small injections into you skin over various areas of your forehead, scalp, neck and shoulders.

This part usually takes 20 mins.


If it is clear it is not suitable for the types of headaches you have,we will dicuss and give other options you can pursue.  There will be a £30 charge for this if no  Botox® treatment is given.


Does it hurt?

At The Head Clinic we do all we can to make it as comfortable as possible.

We will position you so you can relax, and we will administer the series of injections efficiently to minimize discomfort. At the patients request we can apply local anaesthetic cream on areas that are not within the hairline. However without anaesthetic patients describe it as a tiny sting which lasts no more than 2-3 seconds.


Who can inject Botox® for chronic migraine?

At present the use of Botox® is restricted to a few specialist headache centres, but as time goes on there should be increasing numbers of trained injectors available. In all cases, however, you should ensure that the person injecting has received appropriate training, both in the diagnosis and management of chronic migraine, and in the delivery of Botox® according to the proven PREEMPT schedule.

The Head Clinic Ltd Migraine care has been set up alongside Dr Michael Gross who is a leading UK Consultant Neurologist and Migraine specialist .

The treatment will be carried out by Chris Bushell who is an Advanced Nurse Practitioner and independent prescriber who has attended the training for administering Botox®  and received certification. The Head Clinic Ltd  is insured for this procedure  by Hamilton Fraser .


What about Botox® for treating chronic migraine on the NHS

The National Institute for Health and Clinical Excellence (NICE) issued guidance in June 2012 recommending Botox® is made available on the NHS as a preventive treatment option for adult patients with chronic migraine - this applies to NHS settings in England and Wales.  The process for this involves being referred by your GP to a neurologist who will then decide if your headaches classify for under the NHS.


Is Botox® right for me?

Only patients with chronic migraine are eligible for treatment with Botox® on the NHS. Chronic migraine is defined as headaches occurring on 15 or more days each month, at least half of which have migrainous features. There are, however, other treatments available to patients with chronic migraine, and it is important that patients have an informed discussion of their headaches and the options for treatment with a practitioner experienced in the diagnosis and management of headaches before a decision to use Botox® is taken.

If your health professional has recommended that you are suitable for this treatment, but you or your health professional are having difficulty accessing the funding or resources for you to receive Botox® from your local NHS healthcare provider, then The Migraine Trust's advocacy service may be able to provide further support. 


Why are The Head Clinic offering to provide this treatment privately if I can possibly get it free on the NHS?

Several reasons -

  • some patients have had their 2 treatments on the NHS and therefore no longer qualify for further treatment but wish to pay to continue with Botox® .

  • some patients are under a private scheme and may be able to claim it through the private insurance system.

  • some patients may not fit the strict criteria that the NHS insist upon but are still keen to try to see if their headache frequency or severity can be reduced. As long as patients are aware this is off license use (but still considered safe) and they consent knowing this, we are willing to treat.


What if my headaches are not chronic migraines but they mostly affect my forehead area?

In these scenarios you may want to consider the cosmetic use of botulinum toxin as many clients notice after cosmetic treatments that their headaches are improved as a side effect.

Cosmetic use still involves targeting the muscles in the forehead ( Frontalis), frown area (procerus)  and above the eyebrows ( corrugators). This is cheaper than Botox® for Migraine as it is fewer injections.


Please discuss this with Chris and she can advise you of the differences in the treatment process.

If you would like to learn more about headaches please click on the website below which Dr Michael Gross hosts.



head clinic